Type 1 Diabetes MellitusNCT01492062
A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery
A study of Type 1 Diabetes Mellitus, run by Stanford University at 2 sites in United States.
Trial summary
You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor and uses that information to tell an insulin infusion pump how much insulin to deliver. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eligibility
- To be eligible for the study, all subjects must meet the following criteria:
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; Cpeptide level and antibody determinations are not needed.
- Age 21 years to less than 45.0 years
- Subject has used a downloadable insulin pump for at least 3 months
- Subject understands the study protocol and agrees to comply with it
- Informed Consent Form signed
- A Personal Home computer with internet access (must have access to a PC for uploading, not a Mac).
Who cannot join
- Subjects who meet any of the following criteria are not eligible for the study:
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- The presence of any of the following diseases:
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
- Cystic fibrosis
- Other major illness that in the judgment of the investigator might interfere with the completion of the protocol Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
Show all 15Show fewer
- Inpatient psychiatric treatment in the past 6 months
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Pregnancy, breast feeding, or intention of becoming pregnant in the next 2 months.
- Weight less than 26 kg
- Renal failure or peritoneal dialysis
- History of heart disease
- The use of beta-blockers
- History of cerebrovascular disease, or non-hypoglycemic seizures, or intolerance of glucagon treatment.
- History of a hypoglycemic seizure within 6 months of enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CTRU located in Blake Wilbur
Stanford, California, 94305
Stanford University School of Medicine
Stanford, California, 94305
About this study
You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor and uses that information to tell an insulin infusion pump how much insulin to deliver. The primary purpose of this study is to gain experience with insulin delivery algorithms or programs program (algorithm) provides the best regulation of glucose levels so that there are no severe low blood glucose reactions and blood glucose levels are generally between 70 to 180 mg/dl.
Read the detailed description
You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor and uses that information to tell an insulin infusion pump how much insulin to deliver. The primary purpose of this study is to gain experience with insulin delivery algorithms or programs program (algorithm) provides the best regulation of glucose levels so that there are no severe low blood glucose reactions and blood glucose levels are generally between 70 to 180 mg/dl. If the system is working properly, you would not need to enter the amount of food you were eating, give an insulin bolus, or change your basal rates while wearing the device. You would need to periodically check to be sure the continuous glucose sensor was functioning properly and you would need to respond to alarms that might occur if your blood glucose was too high, too low, or the glucose sensor or pump were not working well. In addition to this the investigators will also gain experience with insulin delivery algorithms to minimize the number of glucose readings which are above or below target. It is our intention to modify the algorithms during these studies.
In this study the investigators plan to use a commercially available insulin infusion pump (OmniPod) to deliver lispro (Humalog) insulin. The investigators will use Navigator continuous glucose sensors both to monitor glucose levels (sensor 1) and provide the glucose concentration for the closed loop algorithm (sensor 2). The signal from the second Navigator will be sent by serial cable to a computer which will be at the patient's bedside. A control algorithm will reside on the computer, and the amount of insulin to be delivered will be transmitted to the OmniPod Personal Device Manager which will then send a radiofrequency (rf) signal to the Omnipod pump residing on the subject. A health care provider will be in attendance and monitoring discrete blood glucose levels (YSI, GlucoScout, or HemoCue measurements) at least every 30 minutes. While the Navigator and Omnipod are commercially available they will be used in this study as part of an investigational system while you are in the hospital, an investigational system is one that is not approved for use by the FDA.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Multiple Model Predictive Controller
- Keywords
- Type 1 diabetes mellitus, artificial pancreas, closed-loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Model Predictive ControllerDevice
Also called artificial pancreas
Use of closed loop algorithm in an inpatient environment while closely monitoring blood glucose levels.
| Study group | Role | What they receive |
|---|---|---|
| closed-loop control | Experimental | Multiple Model Predictive Controller Receives: Device: Multiple Model Predictive Controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the feasibility of using MMPPC controller for closed loop insulin delivery in a monitored inpatient clinical research environment.
Safety: 1) No reference glucose values <50 mg/dl, and no more than 30 minutes with reference glucose values between 50-60 mg/dl per day based on linear interpolation between values 3) No reference glucose value >250 mg/dl outside of the 3 hours following a meal.
Measured: 36 Hour Admission
Secondary outcomes (1)
Efficacy
The percent of time spent between 70 mg/dl and 180 mg/dl, mean and standard deviation of measurements.
Measured: 30 hour admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Study halted prior to enrollment of first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce A. Buckingham, Stanford University
- Investigators
- Bruce A. Buckingham, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492062
- Sponsor's protocol ID
- SU-09222010-6910
- Other IDs
- SPO: 47012, eProtocol: 8566
- Status last verified
- Mar 2015
- First submitted
- 14 Jan 2011
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery
- ClinicalTrials.gov ID
- NCT01492062
- Acronym / sponsor ID
- SU-09222010-6910
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, artificial pancreas, closed-loop
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prior to enrollment of first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor and uses that information to tell an insulin infusion pump how much insulin to deliver. The primary purpose of this study is to gain experience with insulin delivery algorithms or programs program (algorithm) provides the best regulation of glucose levels so that there are no severe low blood glucose reactions and blood glucose levels are generally between 70 to 180 mg/dl.
Detailed description
You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor and uses that information to tell an insulin infusion pump how much insulin to deliver. The primary purpose of this study is to gain experience with insulin delivery algorithms or programs program (algorithm) provides the best regulation of glucose levels so that there are no severe low blood glucose reactions and blood glucose levels are generally between 70 to 180 mg/dl. If the system is working properly, you would not need to enter the amount of food you were eating, give an insulin bolus, or change your basal rates while wearing the device. You would need to periodically check to be sure the continuous glucose sensor was functioning properly and you would need to respond to alarms that might occur if your blood glucose was too high, too low, or the glucose sensor or pump were not working well. In addition to this the investigators will also gain experience with insulin delivery algorithms to minimize the number of glucose readings which are above or below target. It is our intention to modify the algorithms during these studies.
In this study the investigators plan to use a commercially available insulin infusion pump (OmniPod) to deliver lispro (Humalog) insulin. The investigators will use Navigator continuous glucose sensors both to monitor glucose levels (sensor 1) and provide the glucose concentration for the closed loop algorithm (sensor 2). The signal from the second Navigator will be sent by serial cable to a computer which will be at the patient's bedside. A control algorithm will reside on the computer, and the amount of insulin to be delivered will be transmitted to the OmniPod Personal Device Manager which will then send a radiofrequency (rf) signal to the Omnipod pump residing on the subject. A health care provider will be in attendance and monitoring discrete blood glucose levels (YSI, GlucoScout, or HemoCue measurements) at least every 30 minutes. While the Navigator and Omnipod are commercially available they will be used in this study as part of an investigational system while you are in the hospital, an investigational system is one that is not approved for use by the FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| closed-loop control | Experimental | Device: Multiple Model Predictive ControllerMultiple Model Predictive Controller |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Eligibility
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; Cpeptide level and antibody determinations are not needed.
- Age 21 years to less than 45.0 years
- Subject has used a downloadable insulin pump for at least 3 months
- Subject understands the study protocol and agrees to comply with it
Key exclusion criteria (15 listed)
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- The presence of any of the following diseases:
- Inpatient psychiatric treatment in the past 6 months
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Pregnancy, breast feeding, or intention of becoming pregnant in the next 2 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Model Predictive ControllerAlso: artificial pancreasUse of closed loop algorithm in an inpatient environment while closely monitoring blood glucose levels. | Device | closed-loop control |
Primary outcome
Test the feasibility of using MMPPC controller for closed loop insulin delivery in a monitored inpatient clinical research environment.
Time frame: 36 Hour Admission
Safety: 1) No reference glucose values <50 mg/dl, and no more than 30 minutes with reference glucose values between 50-60 mg/dl per day based on linear interpolation between values 3) No reference glucose value >250 mg/dl outside of the 3 hours following a meal.
1 secondary outcome
Efficacy
Time frame: 30 hour admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce A. Buckingham principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes Mellitus, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test the feasibility of using MMPPC controller for closed loop insulin delivery in a monitored inpatient clinical research environment. (time frame: 36 Hour Admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.